September 20, 2012

The AIDS Institute Urges Congress and the President to Find Agreement to Prevent Devastating Cuts

WASHINGTON, Sept. 19, 2012 /PRNewswire-USNewswire/ -- In a letter sent to Congressional leaders today, The AIDS Institute outlined $538 million in automatic spending cuts that would occur due to sequestration to four federal programs that people with HIV/AIDS depend upon for their lifesaving care and treatment, or which work to prevent future HIV infections. Unless Congress and the President come to an agreement on another option in the next couple of months, these cuts will automatically occur on January 2, 2013, because an agreement on how $1.2 trillion in budget cuts was not reached.

"With 50,000 new infections each year and a record 1.1 million people living with HIV/AIDS, with only 25 percent of them with a suppressed viral load, our Nation cannot afford to turn its back on addressing the domestic HIV/AIDS crisis," wrote leaders of The AIDS Institute. "It is imperative that alternatives to sequestration be identified and agreed upon by the Congress and the President so that these drastic cuts will not automatically occur."

The cuts of 8.2 percent represent just those that will occur in the first of nine years of planned cuts and are in addition to some previous year funding reductions. Based on a calculation using FY12 spending levels: 1) funding for HIV prevention at the CDC would be cut by $64 million; 2) the Ryan White HIV/AIDS Program, which provides care, treatment and support services to over half a million low income people with HIV/AIDS would be cut by $196 million, including $77 million from the AIDS Drug Assistance Program; 3) AIDS research at the NIH, which benefits both domestic and global AIDS, would be cut by $251 million; and 4) the Housing Opportunities for People with AIDS (HOPWA) program would be cut by $27 million. The total of these first year cuts would be $538 million.

The cut to ADAP could translate into approximately 9,400 patients losing access to their medications.

People with HIV/AIDS, many of whom are very poor, depend on other discretionary and non-discretionary programs in addition to those outlined above to keep them healthy that would also be impacted by sequestration.

In its letter, The AIDS Institute urged the Congress "to find a balanced solution to our Nation's fiscal situation. We understand there are serious budget concerns, but we also know that HIV/AIDS is an infectious disease that must be addressed by public health and our federal government must protect our Nation's most vulnerable, including people living with HIV/AIDS."

The AIDS Institute is a national nonprofit organization that promotes action for social change through public policy research, advocacy and education.

Late in How to Survive a Plague, a fair-minded, careful history of the AIDS-activist movement ACT UP, comes an affecting montage that bears witness to the triumph and the tragedy of the New York-based group's radical crusade — a push to get affordable treatment for a disease that, at its peak in the late 1980s, was killing millions worldwide.

When asked, in the early 1990s, whether they expected to live themselves, not one of the founding members of ACT UP had said yes. Now middle-aged and older, several of those leaders — many of whom have been HIV-positive for 25 years — look healthy and a lot less angry than they did as young firebrands. They're happy to be alive, but they all break down in tears at the thought of the many colleagues who died before they could benefit from the combination drug therapy they'd fought so hard for.

Whether or not you were around in 1987, when ACT UP was born in the wake of a coruscating tirade by playwright Larry Kramer (The Normal Heart), the movie brings fresh news. Noting that the movement's birth coincided with the first camcorders, director David France, a longtime AIDS journalist, dug up a treasure trove of amateur videography chronicling the devastating passage of the disease among friends, family and lovers.

His film is neither circumspect nor obsessive with these difficult images, which France deftly integrates into an inspiring visual chronicle of ACT UP's flamboyant direct-action campaigns — all aimed at shaming government agencies, drug companies and the scientific community into taking swift action to find an affordable treatment.

Frustrated both by the inertia ofindustry and government health agencies on the one hand and the polite diplomacy of older AIDS organizations on the other, ACT UP leaders launched a barrage of theatrical, aggressive and sometimes strategically ill-mannered assaults on public figures.

It's hard to imagine a constituency better suited to putting on a show than New York's LGBT community. Or one with less to lose: Many of them were HIV-positive or had full-blown AIDS and could expect to die young, absent treatment that went beyond the ubiquitous quack remedies or the prohibitively expensive and hard-to-absorb drug AZT.

At 109 minutes, How to Survive a Plague is thorough almost to a fault. The film's villains get damning coverage — Ronald Reagan, New York mayor Ed Koch (who called ACT UP's actions "fascist") and then-President George H.W. Bush and New York archbishop John Cardinal O'Connor, both of whom tried to refocus public attention on promiscuity among some gay men. Meanwhile good eggs like Iris Long, a retired antiretroviral expert who wasn't gay but who counseled ACT UP on how to win reforms from the health agencies, get their due.

Long was among the few outsiders to chip in: Given public reaction to their rowdy methods, ACT UP mostly had to close ranks and rely on cheeky self-help. Refusing to succumb to the wagging fingers of clergy and politicians, members invaded St Patrick's Cathedral and renamed the cardinal "O' Condom." They ruined the president's golf game and wrapped Helms' house in a bright yellow condom. They held sit-ins in the offices of drug companies that overcharged for inadequate therapies; kiss-ins at hospitals where AIDS patients were mistreated or turned away; and "die-ins" at City Hall.

At a huge demonstration in Washington, D.C., they piggy-backed on the publicity generated by the AIDS Memorial Quilt by spilling the ashes of loved ones on the White House lawn. And when the police got rough, they chanted the mantra of the 1960s counterculture that had paved their way: "The whole world is watching."

Most important, the leaders of ACT UP — prominent among them Kramer, former bond trader Peter Staley, writer Mark Harrington and Bob Rafsky, a gifted orator with full-blown AIDS who famously lit into presidential candidate Bill Clinton — educated themselves as clinicians, bullied scientists into letting them in on research meetings and pushed to speed up clinical trials.

Still, research is time-consuming and tempers run short in those desperate times. France neither skirts nor overplays the internal rifts that all but short-circuited the movement's energies.

What saved the day was the stubborn persistence of its members, together with the scientific breakthroughs that led to protease inhibitors and combination therapies. Those new tools restored many near-corpses to life and cut the number of AIDS-related deaths in New York by a staggering 50 percent.

ACT UP soldiers on today, as it must, given the lack of official attention to the resurgence of HIV among young American men in metropolitan areas. The movement is quieter now, though, and by the standards of global street protests these days, its anarchic modus operandi back then may look pretty tame. But in the inward-looking 1980s, ACT UP was the best thing going in direct political action, and given the odds against the group, the magic it worked was remarkable. Occupy movements, take note.

Michael Stravato for The Texas Tribune

Medications, bound for various prisons, on a conveyor belt at the Texas Department ofCriminal Justice’s pharmacy.

The Texas Tribune

By BRANDI GRISSOM

Published: September 20, 2012

Tattooing is ubiquitous behind bars, despite — or perhaps because of — the fact that it is banned.

“It’s just unbelievable how creative they can be,” said Michele Deitch, a prisons expert at the University of Texas at Austin’s LBJ School of Public Affairs. “They can jerry-rig pens to become needles. They use the dyes in paper products.”

But the practice carries with it more than the risk of punishment — it can also spread hepatitis C.

The prison population is particularly prone to this viral disease, which is transmitted largely through infected blood and can lead to liver cirrhosis and cancer. Not only do inmates have a penchant for illicit tattoos, but they are also likelier than the general population to have engaged in high-risk behavior like intravenous drug use outside of prison. Prison health officials estimate that as many as 50,000 of the state’s more than 150,000 inmates could be infected with hepatitis C.

The cost to treat Texas inmates with hepatitis C is expected to soar by as much as 380 percent next year, a result of the growing prevalence of the disease among inmates and a more effective, but more expensive, treatment protocol. Legislators, already facing a strained budget, will have to find millions more dollars to pay for this care.

Not all inmates are tested for hepatitis C when they enter the prison system. They are tested if they have other clinical indicators, like H.I.V. or a history of intravenous drug use. In a 2007 report, health providers for the Texas Department of Criminal Justice said they had identified and were managing care for about 20,000 inmates with hepatitis C.

Dr. Stephanie Zepeda, the director of pharmacy services for University of Texas Medical Branch Correctional Managed Care, which oversees treatment of inmates, said she provided medication therapy for about 400 hepatitis C patients per month, at a cost to the state of about $2.8 million per year. Not all patients with the disease receive the medication, and the therapy can last from three months to a year.

The current protocol is composed of two drugs, and its cure rate is about 40 percent, Dr. Zepeda said. But new medical guidelines call for the use of a third medication, which can be one of two different drugs. One of them would increase the cost of hepatitis C treatment in prisons to more than $8 million a year, the other to more than $13 million, Dr. Zepeda said.

Dr. Zepeda said that adding a third drug raised the cure rate to 70 percent. But the drugs are not only expensive, they are also complicated to administer.

“It’s great from a humanistic standpoint,” Dr. Zepeda said. “But it’s, practically, a challenge for the correctional system.”

The new drugs must be administered precisely every eight hours. They must be taken with food, and patients risk developing a resistance to the therapy if they miss doses. In prison, where even small diversions from the regimented schedule require additional work for guards, and where inmates frequently move between units, ensuring that the expensive medications are given correctly could be problematic, Dr. Zepeda said.

“It just takes a tremendous amount of coordination to do it right and to do it well,” she said.

Another complicating factor, Dr. Zepeda said, is that new, potentially more effective drugs with simpler procedures are expected to be available as early as 2014.

In addition to these changes, the Centers for Disease Control and Prevention issued a new recommendation in August calling for all people born between 1945 and 1965 to be tested for hepatitis C. The C.D.C. estimates that this age group accounts for nearly three-quarters of all hepatitis C cases nationally.

More than a quarter of Texas prison inmates were born during that period, according to The Texas Tribune’s prisoner database. More testing, Dr. Zepeda said, is likely to result in diagnoses of more cases and an increased need for treatment.

For Texas lawmakers, this means high costs now and potentially exorbitant ones in the future as inmates age and the disease progresses, causing liver disease and failure. Additionally, failing to control the disease in prisoners presents serious health risks to the general population. Inmates who are not cured of hepatitis C and are released could spread the disease, which the C.D.C. reports is now the leading reason for liver transplants nationally.

“It is going to be a struggle as the disease continues to wreak havoc in the offender population,” said Dr. Owen Murray, the vice president of U.T.M.B.’s Correctional Managed Care program. (U.T.M.B. is a corporate sponsor of The Texas Tribune.)

Dr. Murray said policy makers should consider ways to control other costs in the prison health care system in order to mitigate the expense of treating hepatitis C. Perhaps, he said, offenders with expensive health needs whose crimes are less severe could be paroled earlier, or state agencies could work with pharmaceutical companies to secure lower rates for drugs. It would be ideal, he said, if the state teamed up with a nursing home to provide care to the growing population of elderly inmates.

Until then, Dr. Murray said, prison health officials will have to consider which patients immediately need hepatitis C treatment, and which ones can wait.

“Ultimately, it’s going to be much like H.I.V.,” Dr. Murray said. “You’re just going to have to acknowledge you have this disease in prison and that it costs a lot to treat.”

Ms. Deitch, the prisons expert, said preventing the use of dirty, homemade needles in prison by providing sterile ones for tattooing could be an inexpensive way to limit the spread of hepatitis C.

“Would you rather make those tools available or deal with the long-term cost consequences of the spread of the disease?” she asked.

Jason Clark, a spokesman for the criminal justice department, said the agency was not considering that, largely because of safety concerns. He said the agency already had rules in place to prevent the spread of diseases, including banning tattoos and sexual contact among inmates, along with the sharing of items like toothbrushes and razors.

In 1998, Mr. Clark said, the department began an education program focused on disease prevention. In the program, which is available in 99 of the state’s 111 prison facilities, 1,300 inmates teach other inmates about risk factors for infection and how to avoid them.

“They’re more likely to have firsthand knowledge about the risk factors among offenders, which gives them credibility,” Mr. Clark said.

State Senator John Whitmire, Democrat of Houston, dismissed the notion of allowing sterile needles in prisons. But he said lawmakers should consider solutions beyond financing medication for inmates.

“This is not just about inmates and their cellmates,” Mr. Whitmire said. “It’s about our communities where these inmates are being released.”

CDC statistics indicate 1 in 30 people born between 1945 and 1965 have hepatitis C, which can lead to liver cancer; early detection can save lives

CHICAGO, Sep 20, 2012 (BUSINESS WIRE) -- Analyte Health, Inc., a privately held online medical services company offering specialty care, counseling and convenience not available in traditional primary care settings, announced today a new campaign to educate the public on high rates of hepatitis C among baby boomers. As part of that campaign, Analyte is offering reduced pricing to encourage more at-risk individuals to get tested through its two online clinics: Sexualhealth.com and STDTestExpress.com.

Hepatitis C is an infectious disease that primarily affects the liver. Individuals infected with hepatitis C often do not have symptoms, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis. In some cases cirrhosis can lead to liver failure, liver cancer or other life-threatening diseases. Data from the Centers for Disease Control (CDC) shows that people born between 1945 and 1965 are five times more likely to have the infection as people born earlier or later.

Analyte's hepatitis C testing campaign, starting first on Facebook, uses infographics to illustrate the sobering statistics, along with testing discounts intended to reach more individuals in the at-risk population. The campaign launches with a tab hosted on the company's Facebook page and 16 Facebook ads reaching 10 segments of the baby boomer population.

"Analyte's new campaign is a direct response to the CDC's initiative to improve screening for hepatitis C in the baby boomer population. Our goal is to get more people tested and improve lives," said Lisa Oldson, M.D., the medical director at Analyte Health.

The CDC reports that more than 15,000 Americans, the majority of which are baby boomers, die each year from hepatitis C and related illnesses, and estimates that testing and early treatment of hepatitis C could save more than 120,000 lives.

Anthony Priore, Analyte Health Chief Marketing Officer, noted that "with more than 4,000 diagnostic labs in our network and doctors licensed in all 50 states, we can offer easy, quick and convenient testing. Social media is our lead marketing channel because of its flexibility and broad reach, and we know that this particular population is very active there."

About Analyte Health, Inc.

Analyte Health is an innovative healthcare company based in Chicago, IL, that uses technology to help people gain greater access to expert medical care and information. Analyte Health delivers specialty care, counseling and convenience not available in a traditional primary care setting. Analyte Health offers individuals access via the web, mobile devices and telephone to a dedicated national team of doctors, nurses and health experts as well as more than 4,000 partner testing centers. Through more than 80,000 patient encounters to date, patients have trusted Analyte Health to deliver discreet and convenient STD testing and care. More information about the company is available at www.AnalyteHealth.com or on Facebook at https://www.facebook.com/SexHealthDotCom , Twitter at https://twitter.com/sexualhealth .

Forward-Looking Statements

Analyte Health, Inc. is a privately held company. This press release may be deemed to contain forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected benefits to consumers from using Analyte Health's services. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual future events or results due to a variety of risks and uncertainties, including, among other things, the potential impact of regulatory and third party payer developments in the field of telehealth and STD testing, general business and economic conditions, changes in arrangements with vendors or suppliers, and costs or delays in obtaining or maintaining regulatory approvals and licenses. Any forward-looking statements in this release are based on limited information currently available to Analyte Health, which is subject to change, and Analyte Health will not necessarily update the information.

"......it was notable that more cirrhotics had worse fatigue than those with minimal fibrosis....."

After treatment results

Once therapy terminated, the proportion of patients who admitted to feeling fatigued decreased. By 12weeks after discontinuation, the proportion of patients with fatigue was lower than that at baseline (36% in responders, 42% non-responders vs. 52% at baseline, Fig. 1A). The median fatigue VAS scores were also lower (11mm in responders, 17mm in non-responders vs. 25mm at baseline: Fig. 1B).

The improvement in fatigue was greater among patients who achieved an SVR than in those who never became HCV RNA negative (non-responders). Overall, the proportion of SVR patients who admitted to having fatigue decreased from 53% at baseline to 33%, 24weeks after treatment (p<0.0001; n=161), and the median VAS fatigue score decreased from 27mm to 13mm (p<0.0001; n=158). These changes were especially profound in patients who at baseline had severe levels of fatigue (fatigue VAS score >40mm), in whom the median fatigue VAS score decreased from 64mm at baseline to 21mm at follow-up week 24 (p<0.0001, n=66; Fig. 3A). Among non-responders, the presence and severity of fatigue decreased but not significantly between baseline and 24weeks after treatment regardless of the initial score (p>0.05, Fig. 3B). Furthermore, there was no significant change in fatigue presence or severity among patients who had virologic relapse (n=60) or breakthrough (n=21) (data not shown).

As expected, fatigue score was associated with depression, (Spearman correlation coefficients, rs=0.53 at baseline; 0.66 at treatment week 24; and 0.73 at follow-up week 24; all p<0.0001). Controlling for the presence of depression did not alter the significance of the changes in fatigue severity after successful completion of therapy compared to baseline (p<0.0001).

Fatigue is perhaps the most common symptom among patients with chronic hepatitis C and is a troublesome side effect of its therapy [1], [2], [4], [7], [9], [34], [35]. In this study, half of the patients enrolled in a study of antiviral therapy of HCV admitted that they had some degree of fatigue, of whom two-thirds rated it as moderate or severe. The current literature suggests that the presence and severity of fatigue correlate poorly with disease activity although it may be somewhat more common and severe in patients with cirrhosis [1], [9], [19], [36]. In the current study, the differences in frequency and severity of fatigue in patients with cirrhosis compared to those with lesser degrees of fibrosis were not statistically significant; however, the data were limited by numbers of patients with more advanced disease (n=29: 7% of the cohort) but it was notable that more cirrhotics had worse fatigue than those with minimal fibrosis.

As expected, fatigue became more troublesome during interferon therapy [9], [14], [15], [18]. Fatigue worsened during the first 4weeks of therapy, then plateaued, and did not completely resolve or return to baseline until 12weeks after stopping therapy. The cause of fatigue induced from interferon therapy is likely multifactorial, but may include the systemic effects of cytokines, secondary effects of treatment-related side effects such as anemia [37], [38], [39], [40], as well as the psychosocial stress of having to maintain occupational and family responsibilities while undergoing medical treatment. Thus, although attributing the cause of fatigue to a specific set of genes or proteins is an attractive and parsimonious notion, an interlinked pathway involving multiple genetic, biochemical, and environmental processes is a more realistic probability [41], and an area for future research.

Importantly, the presence and severity of fatigue ultimately declined in patients with sustained clearance of HCV. The results remained consistent even after controlling for depression, a common cofounder of fatigue. These findings indicate that therapy of HCV can result in significant and sustained improvement in clinical symptoms, and that the measurement of fatigue using VASs is successful in capturing these changes. Improvements in fatigue were most convincing in patients with moderate to severe levels of fatigue at baseline. Thus, patients with relatively non-significant biochemical or histologic disease, but who have troublesome symptoms such as fatigue, should be considered for antiviral therapy.

The likely cause for the improvement of fatigue with eradication of HCV is unclear. It is also unclear whether certain aspects of fatigue (i.e., physical, mental or cognitive) fare better, as the VAS is a quantitative measure rather than a qualitative one. While patient awareness of virological response could have a beneficial psychological effect on perceptions of fatigue, fatigue assessments were obtained before the results of virological testing were known, and improvements in fatigue were achieved well before knowledge of SVR was given to patients.

A few limitations of this study should be noted. The cohort tested was a relatively biased sample of patients with HCV infection, as these subjects all had genotype 1 and all were sufficiently motivated to undergo a rigorous, prolonged medical therapy with notable adverse side effects. Another caveat to consider is that the improvements in fatigue scores were observed predominantly among patients who had moderate or severe levels of fatigue before treatment, and there was little or no improvement in patients who initially reported minimal fatigue. Such findings suggest that there is little room for improvement in fatigue among those with lower levels at baseline, or that the VAS is not sensitive enough to detect minor improvements.

In conclusion, use of a simple fatigue VAS demonstrated that at least half of the patients with chronic hepatitis C who participated in a clinical trial had complaints of fatigue at baseline, however, fatigue significantly improved in those who achieved viral eradication. Further analyses of the quality of fatigue in chronic liver disease, as well as the biologic and psychosocial pathways associated with this subjective symptom are needed to improve management of chronic liver disease and assessment of the benefits of antiviral therapy, whether curative or ameliorative in nature.

Simeprevir is a once daily potent HCV NS3/4A protease inhibitor in phase III clinical development for the treatment of chronic hepatitis C jointly developed by Medivir and Janssen Research & Development Ireland (Janssen). TMC647055 is a potent NNI (non-nucleoside inhibitor) of the HCV NS5B polymerase and is being developed by Janssen R&D.

"This study is in line with Medivir's and Janssen's strategy to evaluate different combination possibilities with simeprevir for interferon-free HCV treatments. This will broaden our understanding of simeprevir, which we believe has the necessary characteristics to potentially become a key component of future hepatitis C treatment regimens, including combination with interferon and ribavirin as well as interferon-free therapies," comments Charlotte Edenius, Medivir's EVP of Research and Development.

Study design

This will be an open label study in patients who are chronically infected with HCV genotype-1a or 1b to assess the efficacy, safety and tolerability of the combination. The primary endpoint in the study will be SVR12 (sustained virologic response 12 weeks after end of treatment). Simeprevir, TMC647055 and low-dose ritonavir will be co-administered once daily, with and without ribavirin.

Approximately 40 patients will be enrolled in this study, which is divided in two parts. The first part will include patients chronically infected with HCV genotype-1, who are either treatment-naive or have relapsed after prior pegylated interferon (PegIFN)/ribavirin treatment. The treatment will consist of simeprevir, TMC647055 and low-dose ritonavir, with and without ribavirin for 12 weeks.

The second part of the trial will investigate the same regimen in prior null responder patients chronically infected with HCV genotype 1a.

Medivir announced today that it has acquired preclinical research stage assets from Novadex Pharmaceuticals AB.

The acquisition includes intellectual property and prodrug technologies in order to further strengthen Medivir's hepatitis C platform and know how.

The acquired portfolio of research stage antiviral programs includes novel nucleotide polymerase inhibitors that have been identified and developed. It also includes prodrug technologies which could be applied to both protease inhibitors and nucleoside analogues to enhance their overall pharmacokinetic properties.

"We are very pleased to be able to make these additions to the Medivir R&D portfolio, which will further strengthen our pipeline and capabilities in the antiviral disease area. There are several synergies with the Medivir anti-viral projects and prodrug approaches which we aim to explore" comments Charlotte Edenius, Medivir's EVP of Research and Development .

The transaction value, which consists of up-front payment as well as future potential milestone payments, is not disclosed.

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